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U.S. Department of Health and Human Services

Safety

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CYPHER Sirolimus-Eluting Coronary Stent Jul 2003

Audience: Cardiologists

Cordis Corporation issued a letter to inform healthcare professionals of a rare but potential risk of thrombosis associated with the use of the CYPHER Sirolimus-Eluting Coronary Stent. The letter provides clarification on the safe use of the product in accordance with the scientific evidence that led to product approval.

The CYPHER stent was approved in April 2003 for patients undergoing angioplasty procedures. Since the product’s introduction it is estimated that over 50,000 patients have received a CYPHER stent. To date, FDA has received 47 Medical Device Reports (MDRs) of stent thrombosis occurring at the time of implantation or within a few days of implantation.

[July 7, 2003 - Letter - Cordis Corporation]
[July 8, 2003 - FDA News - FDA]